Suturing instrument

ABSTRACT

An apparatus and a method for surgical suturing with thread management. An apparatus for tissue suturing comprising a cartridge having a suturing needle having a pointed end and a blunt end, the suturing needle capable of rotating about an axis; a pusher assembly comprising a cartridge holder having a needle rotation drive capable of releasably engaging the cartridge and rotating the suturing needle about the axis; and an actuator capable of releasably engaging the needle rotation drive to rotate the needle rotation drive. A method for suturing tissue comprising placing a suturing device having a cartridge containing a suturing needle to span separated tissue segments; activating an actuator to cause rotational movement of the suturing needle through the separated tissue segments; and deactivating the actuator to stop an advancing movement of the suturing needle to cause a suturing material to be pulled through the separated tissue segments forming a stitch.

RELATED APPLICATIONS

This application is a continuation of and claims the benefit of priorityof U.S. patent application Ser. No. 11/387,127, filed Mar. 22, 2006,which is in turn a divisional of and claims the benefit of priority ofapplication Ser. No. 11/121,810, filed on May 4, 2005, which is in turna divisional of and claims the benefit of priority of application Ser.No. 10/127,254, filed on Apr. 22, 2002, now U.S. Pat. No. 6,923,819,which in turn claims the benefit of priority to U.S. ProvisionalApplication Ser. No. 60/298,281, filed on Jun. 14, 2001. Each of theforegoing patent applications is incorporated by reference herein in itsentirety.

FIELD OF THE INVENTION

The present invention relates to a surgical device for suturing tissue.More particularly, the present invention relates to a suturing devicethat enables the manipulation and control of the suturing needle andsuturing material during operation, and methods for using such a devicefor suturing tissue.

BACKGROUND OF THE INVENTION

Sutures are used in a variety of surgical applications including closingruptured or incised tissue, soft tissue attachment, anastomosis,attachment of grafts, etc. Conventionally, suturing of ruptured orincised tissues, for example, is accomplished by the surgeon passing thesharpened tip of a curved suturing needle with a suture attached to theopposite blunt end of the needle through the incised tissue segments tobe sutured such that the needle tip penetrates the tissue segmentscausing the needle to span the incision. The needle is then pulledthrough the tissue segments manually causing the attached suture tofollow the curved path of the needle. Usually a knot is tied at thetrailing end of the suture to anchor the first stitch. This action isperformed repetitively with application of tension to the needle to pullthe entire suture through the tissue segments through subsequentstitches until the entire incised segments are sutured together with aplurality of stitches.

For example, conventional, open abdominal surgery, including OB-Gynprocedures such as Cesarean delivery, creates a substantial incision(typically eight or more inches in length) in the fascia. In majororthopedic surgery, such as total hip replacement, even longer incisionsin two layers of fascia must be closed. The closure of fascia must bedone carefully at the conclusion of the surgical procedure, prior toskin closure. Closing fascia by hand suturing is a routine, repetitive,and time-consuming procedure. Typical abdominal incisions may take aslong as twenty minutes, while in the case of hip replacement surgery,fascia closure can take even longer. Alternative mechanical suturingdevices, as well as staplers, bone anchors, and suture-based arterialclosure devices have been used as alternatives to hand suturing in otherapplications, since manual suturing is a tedious and the speed of theprocedure is mostly dependent on skill of the surgeon. Moreover, manualsuturing involves the handling and manipulation of a sharp suturingneedle with an instrument such as a needle forceps, which can result inslipping and inadvertent, accidental needle pricks through a surgeon'sor nurse's gloves, posing a potential risk of infection for the surgeon,nurse, staff, and patient. Furthermore, the direct handling of theneedle can cause the needle to become contaminated with pathogenicbacteria that can cause onset of infection at the site of the sutures.There is also a risk of the needle penetrating the bowel and causing aserious, and often fatal infection.

Suturing devices described in the art designed to overcome theselimitations are, however, either unduly complex design and economicallynon-viable or relatively difficult to use and unsuited for precisemanipulation for suturing areas that are not easily accessible. Forexample, the device disclosed in U.S. Pat. No. 4,557,265 has to be heldsideways in relation to the direction of the incision being closed.Another limitation of prior art suturing devices is their inability toprovide positive control over the needle and suture during the suturingprocess. This can result in non-uniform sutures with either overly looseor overly tight stitches, which can cause excessive bleeding and risktearing the repaired tissue in the patient.

A suturing device that maintains a positive control over the suturingneedle and is capable of providing uniform stitches is disclosed in U.S.Pat. Nos. 5,437,681 and 5,540,705. The disclosed device requires a“scissors-like” grip and is operated by the surgeon's thumb thatprovides articulation of the drive mechanism that causes rotation of alinear drive shaft encased in a barrel, which in turn causes a suturingneedle encased in a disposable cartridge mounted at the distal end ofthe barrel to rotate in an advancing motion through the tissue. Thedevice is, however, limited in its efficient operability in thefollowing ways: (1) the rotational direction of the needle and the driveshaft is in a direction that is perpendicular to the device actuatinghandles, thereby rendering the device relatively difficult to manipulateand control, (2) does not allow the user to view the needle and itsprogress through the tissue during the suturing operation, since thebarrel containing the drive shaft leading to the needle cartridge doesnot have an open construction to permit such observation, because theaction of the needle is blocked from user's view by the nature of theinstrument design, thereby making it difficult for the user to positionthe advancing needle with high accuracy along the junction of theincised tissue segments and (3) the rate of needle advancement and,therefore, the size and uniformity of the stitches is essentiallycontrolled by the user by the extent to which the articulation mechanismis depressed, thereby rendering the process of obtaining uniform needlerotation, tissue penetration and suture advancement difficult andentirely dependent on the skill of the user.

SUMMARY OF THE INVENTION

The present invention provides a suturing device that closely emulatesor replicates the manual suturing actions carried out by a surgeon. Thesuturing device of the present invention provides greater ease of useand allows better visualization for the user during its operation thanpresent mechanical suturing methods, while maintaining control overneedle movement, advancement and suturing thread management during allphases of the suturing process, thereby preventing entanglement of thesuturing thread material during needle movement.

A benefit provided the suturing device of the present invention is thatit enables maneuvering a suturing material through a tissue incision ina manner substantially similar to the way a surgeon would do so by hand.In particular, the suturing device first pushes a suturing needle fromthe tail of the needle and drives the point of the needle through thetissue. The device then picks up the point of the needle after it hasbeen driven through the tissue, and pulls the remainder of the suturingneedle and the suture attached to the suturing needle through thetissue. The suturing needle thus consistently follows the arc of its owncurve, which is the preferred method of suturing, in the mostnon-traumatic way of passing a needle through tissue. A benefit providedby the suturing device of the present invention is the ability of thesuturing needle to pull the suturing thread entirely through the tissuesegments being closed, following each stitch. The present invention alsorelates to a suturing device comprising a suturing needle that isprotected by a housing cartridge, whereby the suturing needle is notexposed to or handled directly by the user, thereby precludinginadvertent needle sticks. The configuration of the suturing device ofthe present invention also protects against inadvertent penetration of abowel by the needle, since the cartridge acts as a shield between thebowel and the needle.

The suturing needle of the present invention is configured to fit into acartridge, which in turn, is removably attached to the distal end of thesuturing device. The present invention further provides an actuatingmeans and a shaft and drive assembly that provides a torquing force tothe suturing needle to cause the needle to advance through tissue duringa suturing process without inadvertent retraction.

The suturing device of the present invention offers several advantagesover conventional methods used by surgeons for suturing tissue in thatit provides a hand-held suturing instrument of relatively simplemechanical construction and which requires no external motive source.The present invention provides relative ease of operation for thesurgeon with only one hand, thereby enabling the surgeon to moveobstructing tissue, debris and biological fluids from the suturing sitewith a free hand, while eliminating the need for needle holders, pick-upforceps, and other tools normally required for suturing by hand.Furthermore, the suturing device of the present invention can beconfigured as to length, tip, needle, suture, and needle cartridge sizefor use in conventional open surgery as well as in minimally invasivesurgery (MIS) and in “less-invasive” surgery, such as through naturalorifices or through small incisions. Additionally, the suturing head canbe oriented in any preferred direction and either fixed in a particularorientation, or rendered movable in a variety of orientations by anarticulation means.

These and other advantages of the present invention will be obviousthrough the embodiments described hereinafter. The present inventionaccordingly comprises the features of construction, combination ofelements and arrangement of parts that will be exemplified in thefollowing detailed description.

The surgical suturing device of the present invention is configured toprovide a “pistol like” grip for the user that includes a barrelassembly and a handgrip that extends from the proximal end of thebarrel. The barrel assembly has either a linear or non-linearconfiguration, including but not limited to, straight, curved and angledconfigurations. The barrel assembly comprises a plurality of hollowsegments capable of being coupled together by one or more universaljoints that do not require a permanent connection between the segments,enabling segments to be pulled apart individually and separated. Acartridge holder is removably attached to the distal end of the barrelassembly by a plurality of support arms to which is releasably mounted adisposable cartridge that is capable of accommodating a suturing needleand a suturing thread material.

The disposable cartridge has a generally cylindrical housing with anaperture in the sidewall of the housing at the distal or working endthereof. An arcuate suturing needle having a sharp, pointed tip at oneend of the needle is slidably mounted in a circular track at the distalend of the housing and opposite to the location of the aperture. Theneedle is connected to a terminal end of a suturing material or threadwith a suturing thread source, such as for example, a spool assemblythat is contained either entirely within, or remains external thecartridge. The radius of the arc defining the arcuate suturing needle isapproximately equal to the circumference to the cartridge housing at theaperture therein. The needle normally resides in a “home” position inits track such that the gap in the arcuate suturing needle is inalignment with the aperture in the cartridge housing. The sharp, pointedend of the needle is situated on one side and entirely within theconfines of the housing aperture; the pointed end is, therefore, alwaysshielded by the cartridge housing. The blunt end of the suturing needlethat is attached to the suturing thread is located at the opposite sideof the aperture. The sharp, pointed end of the needle is, therefore,wholly contained within the cartridge and does not protrude and beexposed to the user.

In accordance with the present invention, the needle may be releasablyengaged by a driving means that is rotatably mounted within the barrelassembly so that the needle can be rotated from its home position byabout 360° about the central vertical axis of the cartridge. Such arotatory action of the needle causes its sharp tip to advance across thecartridge housing so as to span the aperture. Thus, when the device ispositioned such that the incised tissue segments to be sutured aresituated at the housing aperture, the needle penetrates the tissuesegments and spans the incision between them. A continued rotatorymovement of the needle causes it to return it to its original “home”position, and thereby causes the suturing thread attached to the needleto be pulled into and through the tissue in an inward direction on oneside of the tissue incision, and upwards and out through the tissue onthe opposite side of the incision. Thus, the suture follows the curvedpath of the needle to bind the tissues together with a stitch of threadacross the incision in a manner identical to that of a surgeon suturingmanually, wherein the needle is “pushed” from the tail and then “pulled”from the point by the drive mechanism. Preferably, an anchoring means isprovided at the trailing terminal end of the suturing material toprevent the material from being pulled completely through and out of thetissue segments. For example, the anchoring means can be a pre-tied or awelded loop, a knot wherein the suture is simply tied, or adouble-stranded, looped suture is that attached to the suturing needle.

The rotatory movement of the needle within the needle cartridge isaccomplished by a needle driver that may be operated by the user byholding the suturing device with one hand in a pistol-like grip aroundthe handle, and using at least one finger of that hand to activate atriggering lever. The suturing device includes a finger operated triggerlever located proximally to the handle, which when actuated, operates adrive shaft encased within the universal joint barrel assembly through adrive mechanism so as to cause the drive shaft to undergo a rotatorymotion, thereby causing the suturing needle to advance in a circularmotion. Thus, by placement of the device with the needle cartridgeaperture spanning the incised tissue segments and actuating the triggerlever, the suturing device enables the user to lay down a running stitchor interrupted stitch to close the tissue incision in a time efficientmanner.

The needle cartridge of the present invention is disposably mounted on acartridge holder assembly that is removably attached to the distal endof the universal joint barrel assembly. The cartridge holder assembly issupported by a plurality of support arms that extend from the distal endof the universal joint barrel assembly. The minimalized structuraldesign of the support arms enables the user to have a clear,unobstructed view of the suturing needle as it advances through thetissue segments during the course of a suturing operation, therebyenabling precise placement of the suturing device to provide uniformsutures and precluding the risk of tearing tissue by its placement tooclose to the edge of the incision. The suturing device of the inventionis then advanced a short distance along the incision and theaforementioned operation is repeated to produce another stitchcomprising the suturing material. The suturing device of the inventioncan either pull the entire suture material through the tissuesautomatically under controlled tension thereby replicating the actionsof a surgeon suturing manually so as to tighten the formed stitcheswithout tearing tissue. Alternatively, the surgeon simply pulls thethread by hand to tighten the stitch placed over the incised tissuesegments by passage of the suturing needle of the suturing device of theinvention.

The user may continue to manipulate the suturing device, alternatelyadvancing and actuating rotation of the needle about an axis that isgenerally parallel to the direction of advancement to create acontinuous suture which may extend through the entire length of theincision or a series of interrupted stitches. After each individualstitch is laid down, it is tightened by exerting a pull on the suturingmaterial so that the resultant suture is neat and tensioned uniformlyalong the length of the incised tissue segments. Therefore, a tightclosure of the segments is accomplished and bleeding and tearing oftissue are minimized.

As will be described in greater detail below, the needle driver may beoperated by the surgeon holding the instrument with one hand, and usingat least one finger of that hand. The suturing device includes afinger-operated lever that is functionally coupled with internal gearingand forms part of a handgrip that is located at one terminal end of thedevice, that enables the surgeon to efficiently and effectively lay downa running stitch, or a series of interrupted or uninterrupted stitches,to close a tissue incision in a minimum amount of time.

The suturing device of the present invention can additionally include anassociated thread management system, which operates in conjunction withthe needle driver to control or handle the suturing material or threadduring rotation of the suturing needle. For example, the threadmanagement roller pushes the thread away from the track so the suturedoes not get pinched by the needle as the needle re-enters the track.Thus, there is minimal probability of the thread becoming tangled orhung up during the suturing operation. The thread management system canalso include a mechanism whereby the suturing material or thread iscontrollably “paid out” during the suturing process.

When using the suturing device of the present invention, no ancillaryinstruments or tools such as needle holders, pick-up forceps or the likeare needed to complete the suture. Also, the suturing device may beconfigured in different ways with respect to length and angle of theuniversal joint barrels, the angle between barrel segments and thenumber and shape of the support arms. The size of the needle, needlecartridge, cartridge aperture and aperture position may also be variedfor use in open surgery to perform procedures such as closing of thefascia, skin closure, soft tissue attachment, anastomosis, fixation ofmesh, grafts and other artificial materials. The suturing device or thepresent invention may also be designed with a very small working end ortip at the end of a long rigid shaft or a flexible shaft that can beoriented in any preferred direction so that the instrument may be usedfor MIS, such as suturing in the course of endoscopic surgery, includinglaparoscopy, thoracoscopy and arthroscopy, as well as less-invasivesurgical procedures.

The disclosure also provides a suturing device that includes a curvedneedle and a needle rotation drive for driving the needle through acircular path and an anti-rotate member defining a body for controllingthe direction of needle rotation. The curved needle includes a curvedtoroidal body that defines a longitudinal axis along the curved toroidalbody, wherein the longitudinal axis defines a center point, wherein thecurved toroidal body includes a radially inner surface, a radially outersurface, a first sharp pointed end and a second end, and wherein thelongitudinal axis and the center point of the curved toroidal bodydefine a first plane. The needle further includes a first notch locatedproximate the first sharp pointed end of the curved needle and on theinner radial surface of the curved needle, the first inner notchincluding a first engagement surface configured for engaging the needlerotation drive, wherein the first engagement surface is positionedperpendicularly with respect to the first plane and wherein the firstengagement surface lies on the same geometric plane as a first crosssectional plane of the curved toroidal body. The first cross sectionalplane is also positioned perpendicularly with respect to the firstplane. The needle further includes a second notch located on the curvedneedle; the second notch including a second engagement surface, whereinthe second engagement surface is positioned perpendicularly with respectto the first plane and lies on the same geometric plane of a secondcross sectional plane of the curved toroidal body, wherein the secondcross sectional plane is positioned perpendicularly with respect to thefirst plane, and wherein the second engagement surface is configured forengaging the body of the anti-rotate member for controlling thedirection of needle rotation.

In accordance with a further aspect, the curved toroidal body can havean arcuate extent of less than about 330°. The curved toroidal body canhave a round cross section through a majority of its length. The curvedneedle can further include an attachment point defined on the curvedtoroidal body capable of receiving suturing material. The attachmentpoint can include an aperture for receiving suture material. The devicecan further include suture material held in place at the attachmentpoint. The attachment point can be located at the second end of theneedle. If desired, the curved toroidal body has an arcuate extentbetween about 180° and about 330°. Preferably, the needle has an arcuateextent more than about 180°.

In accordance with a further aspect, a suturing device is provided thatincludes a curved needle and a needle rotation drive for driving theneedle through a circular path and an anti-rotate member defining a bodyfor controlling the direction of needle rotation. The curved needleincludes a curved toroidal body that defines a longitudinal axis alongthe curved toroidal body, wherein the longitudinal axis defines a centerpoint, wherein the curved toroidal body includes a radially innersurface, a radially outer surface, a first sharp pointed end and asecond end, and wherein the longitudinal axis and the center point ofthe curved toroidal body define a first plane. The needle furtherincludes a rear notch located proximate the first sharp pointed end ofthe curved needle and on a rear surface of the curved needle disposedbetween the radially inner surface and the radially outer surface. Therear notch includes a first engagement surface configured for engagingthe needle rotation drive, wherein the first engagement surface ispositioned perpendicularly with respect to the first plane and whereinthe first engagement surface lies on the same geometric plane as a firstcross sectional plane of the curved toroidal body, wherein the firstcross sectional plane is also positioned perpendicularly with respect tothe first plane. The needle further includes a second notch located onthe curved needle. The second notch includes a second engagementsurface, wherein the second engagement surface is positionedperpendicularly with respect to the first plane and lies on the samegeometric plane of a second cross sectional plane of the curved toroidalbody, wherein the second cross sectional plane is positionedperpendicularly with respect to the first plane, and wherein the secondengagement surface is configured for engaging the body of theanti-rotate member for controlling the direction of needle rotation.

In accordance with a further aspect, the curved toroidal body can havean arcuate extent of less than about 330°. The curved toroidal body hasa round cross section through a majority of its length. The curvedneedle can further include an attachment point defined on the curvedtoroidal body capable of receiving suturing material. The attachmentpoint can include an aperture for receiving suture material. Suturematerial can be held in place at the attachment point. The attachmentpoint can be located at the second end of the needle. The curvedtoroidal body can have an arcuate extent between about 180° and about330°. The needle can have an arcuate extent more than about 180°.

The disclosure further provides a removable cartridge for attachment toa suturing device. The cartridge includes a generally circular,“C”-shaped body having a diameter, a first end and a second endseparated by an aperture. The body includes an inner peripheral wallthat at least in part defines a circular track for receiving a suturingneedle, and at least one engagement surface for engaging a distal end ofa suturing device, wherein the body has a height perpendicular to acircular plane defined by the needle track, wherein the height issubstantially less than about one half of the diameter of the body. Thecartridge further includes a toroidally shaped suturing needle disposedin the circular track having a first sharp pointed end and a second end,wherein the needle is adapted and configured to advance along the trackbut is prevented from falling out of the track by at least oneprotrusion extending radially inwardly from the inner wall.

In accordance with a further aspect, the body can further define a cleatfor receiving suture material. The cleat can depend downwardly andradially outwardly from a distal face of the body. The cartridge canfurther include a suture attached to the second end of the needle,wherein the suture is adapted to be received by the cleat to managepassage of the suture material therethrough when the cartridge isengaged with the suturing device. The engagement surface on thecartridge can include at least one clip extending from the body forengaging the suturing device. The engagement surface can include asurface defined by at least one opening formed in the body for engagingthe suturing device. The body of the cartridge preferably traverses anarc greater than about 180 degrees. The cartridge can include apositioning pin disposed thereon capable of engaging a slot in thesuturing device to facilitate alignment of the cartridge with respect tothe suturing device. The cartridge can be enclosed in a sterilizedsealed package. The needle can include a notch on a radially outer edgeof the needle, the notch being adapted and configured to engage a bodyof an anti-rotate member for controlling the direction of needlerotation.

In further accordance with the disclosure, a removable cartridge forattachment to a suturing device is provided, including a generallycircular, “C”-shaped body having a diameter, a first end and a secondend separated by an aperture. The body includes an inner peripheral wallthat at least in part defines a circular track for receiving a suturingneedle, a cleat for receiving suture material, and at least oneengagement surface for engaging a distal end of a suturing device,wherein the body has a height perpendicular to a circular plane definedby the needle track, wherein the height is substantially less than aboutone half of the diameter of the body. The cartridge also includes atoroidally shaped suturing needle disposed in the circular track havinga first sharp pointed end and a second end, wherein the needle isadapted and configured to advance along the track but is prevented fromfalling out of the track by at least one protrusion extending radiallyinwardly from the inner wall. The cartridge further includes a sutureattached to the second end of the needle, wherein the suture is adaptedto be received by the cleat to manage passage of the suture materialtherethrough when the cartridge is engaged with the suturing device.

In addition to offering all of the advantages discussed above, thesuturing device of the present invention is relatively simple and costefficient to manufacture. Therefore, the suturing device should findwidespread suturing applications that include single stitches orcontinuous stitches, e.g. spiral, mattress, purse string, etc., that arerequired to close tissue incisions, attach grafts, or the like.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be further explained with reference to theattached drawings, wherein like structures are referred to by likenumerals throughout the several views. The drawings shown are notnecessarily to scale, with emphasis instead generally being placed uponillustrating the principles of the present invention.

FIG. 1 shows a pictorial view of the suturing device of the presentinvention including the main components of a cartridge, a cartridgeholder assembly, drive shaft segments, a universal coupling jointassembly and a sleeve, an actuator handle with an actuating trigger.

FIG. 2 shows a sectional view of the shaft-universal joint assemblyattached to one embodiment of the suturing device functional endcomprising the pusher, cartridge assembly and cartridge operable by aside drive mechanism.

FIG. 3A shows a segmented sectional view of suturing device functionalend comprising a universal joint assembly without and with the universaljoint sleeve. FIG. 3B shows an identical view with the universal jointsleeve.

FIGS. 4A, 4B and 4C show enlarged views of a single universal joint,joint coupler and a pair of coupled universal joints respectively.

FIG. 5 shows an expanded view of the universal joint sleeve configuredat a 30° angle.

FIG. 6 shows a detailed view of one embodiment of a cartridge mountassembly comprising pair of supporting arms and a shaft segment.

FIGS. 7A and 7B show two different views of one embodiment of the needlecartridge.

FIGS. 8A and 8B show two embodiments of the curved suturing needle withsuture material ports that are operable by a side drive mechanism.

FIG. 9 shows an expanded view of the thread management roller housed inthe cartridge.

FIG. 10 shows an expanded view of the “anti-rotate” pin housed in thecartridge assembly.

FIG. 11A shows an expanded view of the pawl. FIG. 11B shows an expandedview of the pusher comprising a cartridge holder support arm with thepawl in place.

FIG. 12 shows a cut-away segment view showing interaction points of asuturing needle with a cartridge holder and support arm components.

FIG. 13 shows a segmented view of the relative configuration of asuturing needle with respect to the cartridge holder.

FIG. 14 shows a segmented sectional view of the functional end of asecond embodiment of the suturing device operable by a rear drivemechanism comprising a shaft segment, the pusher, cartridge holder andcartridge (shown sectionally in FIGS. 15-19).

FIG. 15A shows a perspective view of a pusher with a cartridge holderassembly comprising an attached cartridge with a suture threadingmechanism for restraining a suture material.

FIG. 15B shows a pusher comprising the cartridge holder assembly and acut-away section of a cartridge comprising the curved suture needle thatis operable by a rear drive mechanism.

FIG. 16 shows an expanded view of a curved suturing needle with suturematerial port that is operable by a rear drive mechanism.

FIGS. 17A and 17B show front and rear views of the cartridge.

FIG. 18 shows a cut-away sectional top view of a pusher comprising acartridge holder assembly with a locking gate.

FIGS. 19A, 19B and 19C shows the operation of the pusher arm in acartridge assembly operating in a rear drive mode. The pusher armtraverses radially by opening the gate (FIG. 19A), which springs to theclosed position (FIGS. 19B and 19C) after its passage.

FIGS. 20A, 20B and 20C show a three-dimensional, a sectional and across-sectional view, respectively, of a ratchet assembly of the presentinvention that is driven by a drive shaft and activates a pusher armupon device actuation.

While the above-identified drawings set forth preferred embodiments ofthe present invention, other embodiments of the present invention arealso contemplated, as noted in the discussion. This disclosure presentsillustrative embodiments of the present invention by way ofrepresentation and not limitation. Numerous other modifications andembodiments can be devised by those skilled in the art which fall withinthe scope and spirit of the principles of the present invention.

DETAILED DESCRIPTION

The suturing device of the present invention is shown generally at 1 inFIG. 1. Referring to FIG. 1, the suturing device 1 of the presentinvention can be used to produce a continuous or interrupted stitch orsuture so as to enable closure of the segments of an incised tissue. Thesuturing device 1 includes an actuator handle 12 comprising a proximalend 6 and a distal end 8, that allows the device 1 to be held in apistol grip by the user, and a trigger lever 16. The actuator handle 12is attached to a pusher 9 at the distal end of handle 12. The pusher 9comprises a of shaft barrel assembly 10 comprising a plurality of shaftsegments capable of housing a drive shaft (not shown) that extendoutwardly from a housing 14 at the distal end 8 of the actuator handle12. The shaft barrel assembly 10 is comprised of at least two segmentswith symmetric coupling assemblies that are coupled to one another witha universal joint coupler (not shown). The coupled assembly is enclosedwithin a universal joint sleeve 18 such that the universal joint barrelis configured at an angle of about 30° from horizontal. The shaftsegment 10 distal from the actuator handle 12 is attached removably to asupport arm assembly 22 that is comprised of a pair of “skeletalized”arms extending along mutually divergent axes so as to provide an opening23 to view the device working end 19 during its operation. The workingend 19 of the suturing device 1 comprises a cartridge holder assembly 20that is removably attached to the support arm assembly 22, to which theneedle cartridge 24 is disposably attached.

FIGS. 2-13 provide detailed views of the various components of oneembodiment of the suturing device 1 and the manner in which thecomponents are configured in the final assembled device to enable itsoperation via a “side-drive” mechanism in the manner described.

FIG. 2 shows the working end 19 of the suturing device 1 including theuniversal joint coupling sleeve 18, the universal joint segment distalto the actuator handle (not shown) a “pusher” 9 comprising a support armassembly 22 and a cartridge holder assembly 20 with an attacheddisposable needle cartridge 24, and a universal joint assembly (hidden)encased in a joint sleeve 18.

FIGS. 3A and 3B provide detailed segmental views of the suturing deviceworking-end 19 showing the disposable needle cartridge 24 in adisengaged mode and a curved suturing needle 26 separated from theneedle cartridge 24 to illustrate the relative configuration of thesesegments with respect to the cartridge holder assembly 20, the pusher 9comprising the support arm assembly 22 and the universal joint segments.FIG. 3A shows the coupled junction mode involving coupling of the shaftsegments 10 comprising a universal joint coupler (hidden), while FIG. 3Bshows the coupled shaft segments 10 encased in a coupling joint sleeveor “sweep” 18 that aligns the cartridge mount 20 from the stem to theactuator handle at about 30°. The sweep 18 can be either pre-configuredto provide a pre-determined fixed angle for the cartridge mount(relative to actuator handle), or can be configured to be adjustable toprovide the user with the ability to vary the cartridge mount angle to asetting optimal for a particular procedure.

FIGS. 4A-C show expanded views of the hollow universal joint segment andthe manner in which two identical segments are coupled. As shown in FIG.4A, the shaft segment 10 comprises a hollow cylindrical barrel 28 withtwo open ends, and two pairs of arcuate slots 32 and 34 at one end,wherein one pair of arcuate slots is narrower than the other.Additionally, the joint segment contains a plurality of circularopenings 36 located on the cylinder surface to accommodate acorresponding number of restraining pins in the universal joint sleeve(“sweep”) 18 that are identical in diameter. Two shaft segments 10having identical arcuate slot configurations 32 and 34 may be coupledtogether using a universal joint coupler 38 (FIG. 4B) comprising aplurality of pins 40 such that the coupler engages the pair of narrowslots 32 of the conjoining joint segments 32, thereby providing ajunction connecting the two shaft segments 10 that is non-rigid (FIG.4C). The angle between coupled segments 10 can, therefore, be varied.The coupled segments 10 provide a conduit for passage of a drive shaft(not shown) for activating needle movement.

FIG. 5 shows a “transparent” view of the universal joint sleeve or“sweep” 18, which comprises of a hollow tubular segment with two openends 29, 31 whose tubular axis bends over a predetermined angle. Thesleeve 18 additionally comprises a plurality of slots 30 positionedalong its side wall that are capable of engaging the corresponding slots36 on the shaft segments 10 that are positioned appropriately by meansof restraining bolts on pins 38. The sweep 18 therefore, enables theangle of the coupled shaft segments 10 to be “locked” in a preferredangle. The sleeve 18 can be configured to have either a fixed angle, orto have the capability to provide the user the ability to adjust theangle to a preferred setting. In one embodiment, the sweep 18 providesan angle of about 30° from horizontal. The angle for the coupleduniversal joint segments 10 determined by the sweep in turn, determinesthe angle of the cartridge holder assembly 20 which is attached to theshaft segment 10 at the distal end 8 of the actuator handle 12 (via thesupport arm assembly 22). The cartridge holder angle relative toactuator handle 12, in turn, determines the accessibility of thesuturing device 1 at the site of the suturing procedure which iscritical, depending on whether it is open and planar, or non-planar andnarrow.

FIG. 6 shows a detailed view of the pusher 9 that includes a cartridgeholder assembly 20 that is attached to a support arm assembly comprisinga pair of “skeletalized” support arms 22 which in turn, is attached tothe terminal end of shaft segment 10. The open configuration of the“skeletalized” support arms 22 that are minimal in bulk is an essentialfeature of suturing device 1 that provides a relatively wide opening 23that allows the user to directly view the aperture in the needlecartridge and cartridge (not shown) holder assembly 20, the incision inthe tissue and needle advancement through the incised tissue segmentsduring operation of suturing device 1. Although the embodiment shown inFIG. 6 has a plurality of support arms 22, other variants include asupport arm assembly comprising a single support arm as illustrated inFIG. 11B. The improved viewing ability offered by the shape andconfiguration of the support arm assembly 22 enables precise deviceplacement over the incision, and uniform advancement of the suturingdevice after every stitch to provide a uniform and symmetric suture,thereby minimizing the risk of tearing tissue and bleeding due to astitch being positioned too close to the edge of the incised tissue. Thecartridge holder assembly 20 is composed of a sterilizable medical gradematerial which can either be a metallic material such as stainless steelto enable its reuse subsequent to sterilization following a prior use,or a sterilizable medical grade plastic material, in which case, it maydiscarded and disposed after a single use. The cartridge holder assembly20 has a cylindrical configuration with a distal edge 40 and a proximaledge 42 with respect to the device actuator handle (not shown), with anaperture 45 that corresponds in dimension and location to coincide witha substantially similar aperture located in the disposable needlecartridge. The cartridge holder assembly 20 additionally comprises aplurality of slots 44 located along on the distal edge 40 in that arelocated diametrically opposite to one another, and are capable ofengaging the same plurality of retaining clips correspondingly locatedin the needle cartridge housing (not shown). The cartridge holderassembly 20 further comprises a cylindrical slot 46 located on thedistal edge 40 that is capable of engaging a positioning pin ofidentical diameter correspondingly located on the needle cartridgehousing (not shown). The proximal edge 42 of the cartridge holderassembly is attached to the shaft segment 10 distal to the actuatorhandle 12 via a support assembly comprising at least one “skeletalized”support arm 22.

FIGS. 7A and 7B show two different views of an embodiment of adisposable suturing needle cartridge 24 of the present invention, whichis preferably offered in a sterilized sealed package. The cartridge 24comprises a circular housing 48 that may be formed of a suitable rigidmedical grade sterilizable metal or plastic material. The housing may bereleasably retained by the cartridge holder assembly 20 at the distalend 19 of suturing device 1 (working end) by known means, such as aplurality of clips 50 (shown in FIG. 7A) located along on the edge of aninner lip 52 in diametrically opposite positions that are capable ofengaging the same plurality of slots correspondingly located in thecartridge holder assembly 20. The cartridge 24 further comprises acylindrical positioning pin 54 located on the edge of the inner lip 52that is capable of engaging a cylindrical slot of identical diametercorrespondingly located on the cartridge holder assembly 20. While theretaining clips 50 when engaged enable the cartridge to be retained bythe cartridge holder assembly 20, the positioning pin 54 when engaged inthe slot causes the aperture in the cartridge 24 to be aligned with thecorresponding aperture in the cartridge holder assembly 20. The needlecartridge 24 further comprises an aperture 56 and a circular groove or“track” 58 that is inscribed in the inside surface of the housing 48,which lies in a plane that is perpendicular to the longitudinal axis ofboth the housing 48 and that of the suturing device 1. As shown in FIG.7A, the cartridge-housing aperture 56 interrupts the track 58. Anarcuate surgical suturing needle 26 composed of medical grade stainlesssteel or similar material is slidably positioned in the track 58.

With further reference to FIGS. 7A and 7B, it will be appreciated bythose of skill in the art that cartridge 24 includes a generallycircular, “C”-shaped body B having an outer diameter D, a first end 24 aand a second end 24 b separated by an aperture 56. The body traverses anarc greater than about 180 degrees, and includes an inner peripheralwall C that at least in part defines a circular track T for receivingsuturing needle 26. Body B further includes at least one engagementsurface S for engaging a distal end of the suturing device. Body B has aheight H perpendicular to a circular plane defined by the needle trackT, wherein the height is substantially less than about one half of thediameter D of the body B. In the depicted embodiments of cartridgesherein, H is less than about one quarter of the diameter D of the bodyB. As is also evident, needle 26 is disposed in track T and isconfigured to advance along the track T but is prevented from fallingout of the track T by at least one protrusion 24 c extending radiallyinwardly from the inner wall C. It will be appreciated that thecartridge embodied in FIG. 17(A) has a body B with a diameter D andheight H that are very similar to the embodiment of FIG. 7(A). However,the cartridge of FIG. 17(A) additionally includes a cleat 98 thatdepends downwardly from the distal face W of the cartridge (that is, theface that forms the distal end of the suturing instrument when thecartridge is installed). Cleat 98 also depends radially outwardly withrespect to the central axis of the suturing instrument and terminates intip 98 a, wherein the cleat cooperates with the body B to define a gap Gtherebetween for receiving and guiding suturing material.

FIGS. 8A and 8B show embodiments of the arcuate suturing needle 26 ofthe present invention. In one embodiment (FIG. 8A), the needle 26 isformed as a circular split ring with a gap 59, a sharp, pointed end 60,and a blunt end 62. The needle 26 further comprises an opening toaccommodate the leading end of the suturing material. In one embodiment,the opening is the form of an eye 64 though which the leading end of thesuturing material may be passed through for attaching it to the needle26. In the illustrated needle (FIG. 8A), the eye 64 is located adjacentto the blunt end 62. The eye 64 however, can be positioned anywherealong the arc or the needle 26 between its apex 61 and the blunt end 62.In a preferred embodiment (FIG. 8B), the needle 26 comprises an openingin the form of a cylindrical bore 66 aligned axially with respect to theneedle 26, located at the blunt end 62 (FIG. 8B). The leading end of thesuturing material is inserted into the bore and restrained bymechanically crimping. To enable the needle 26 to penetrate tissue tothe required depth, the needle preferably has an arcuate extent betweenabout 280° and about 330°, and more preferably, greater than about 270°.The needle 26 comprises two symmetric notches 68 along the radiallyinner edge (“inner notches”) that are positioned proximally to thesharp, pointed end 60 and the blunt end 62 of the needle 26. The notches68 are located directly opposite to each other, each having aperpendicular (about 90°) segment and an angular segment that makes anangle of about 60° with the perpendicular segment. The inner notches 68are engaged by the drive mechanism in the cartridge holder assembly 20and enable the needle 26 to undergo a rotatory movement upon actuationof the drive mechanism, thereby causing it to penetrate into and advancethrough tissue. A similar triangular notch 70 is located on the radiallyouter edge (“outer notch”) of the needle proximally to the inner notch68 closer to the sharp, pointed end 60. The outer notch 70 engages withan “anti-rotate” pin located in the cartridge holder assembly 20,whereby rotation of the needle 26 in a direction opposite to theadvancing direction or “needle backing-up” is prevented. The positiveengagement of the needle outer notch 70 during operation of the suturingdevice 1, and thereby precludes needle 26 from straying out of sequenceduring the suturing process.

The width of the aperture 56 in the cartridge housing 48 is comparableto and corresponds with the width of the gap in the needle 26 so thatwhen the needle 26 is in the “home” position (as shown in FIG. 7A) itdoes not project materially into the aperture 56. Such an alignmentcauses the needle to reside entirely within the cartridge holder 20,thereby preventing inadvertent contact of the sharp pointed end 60 withthe user's fingers during handling of the disposable needle cartridge 24for its placement on the cartridge holder 20 or its disposal after use,and while operating the suturing device 1. Such protection of the needle26 in the suturing device of the present invention prevents accidental“needle-pricks” from occurring, thereby substantially reducing the riskof infection caused by pathogenic bacteria or viruses that maycontaminate the needle during or after its use prior to its disposal.The needle 26 may be rotated in its curved track 58 about thelongitudinal axis of the suturing device 1 to advance the pointed needletip 60 so that the needle first spans the aperture and then return toits original or home position. Since the suturing material is attachedto the needle 26, it follows the path of the needle 26. The terminal endof the suturing material may contain a knot or button to prevent it frompulling through the sutured tissue during placement of the first stitch.The suturing material or thread may be stored in an enclosed packagingeither externally or internally with respect to the needle cartridgehousing 48, and be pulled out of that packaging prior to placement ofthe first stitch in the suturing process. In a preferred embodiment, thecartridge housing 48 comprise the suturing needle 26 attached to theterminal end suturing material or thread, and an appropriate length ofsuturing material are all packaged in a terminally sterilizable medicalpackaging material.

FIG. 9 shows a thread management roller 72 of the present inventionwhich acts to push the thread away from the track so the suture does notget pinched by the needle as the needle re-enters the track. The threadmanagement roller 72 comprises a spring operated stop pin 74 thatmaintains a positive pressure against the suturing material or thread,thereby preventively retaining the suturing material in the threadretaining slot of the suturing needle, while keeping the thread out ofthe needle track to preclude the thread from jamming needle movement.The stop pin 74, therefore, prevents jamming of needle movement by aninadvertent entry of the suturing material into the needle slot withinthe needle cartridge 24 when the material is pulled forward by theadvancing movement of the needle 26.

FIG. 10 shows an expanded view of the anti-rotate pin 75 that is capableof engaging the outer notch of the needle 26 to prevent rotation of theneedle 26 and prevent “needle backing-up” and thereby precluding theneedle 26 from straying out of sequence.

FIG. 11B shows an expanded view of a pusher assembly comprising pusher76 and a pawl 78 (FIG. 11A) located at its tip, which resides in acorresponding slot in the support arm 22 of the pusher assembly, and isconnected the support arm 22 by a pivot pin 80. The needle 26 is drivenin a circular path by a rigid arm (“pusher”) that extends from a hublocated in the center of the suturing device 1. The pawl 78 at the tipof the pusher 76 is capable of interfitting with the wedge shapednotches located along the radially inner edge of the needle. The pusher76 is activated by the user upon operation of the actuator trigger inthe actuator handle 12, and is capable of sweeping back and forth in anarc spanning about 280°. The outer surface of the pusher 76 is shaped toaccommodate a C-shaped spring (not shown) that causes the wedge-shapedpawl 78 to push up against the needle 26 and thereby remain in intimatecontact. The advancing movement of needle 26 during its operation causesthe triangular slots 68 along the radially inner edge of needle 26 alignwith the wedge-shaped pawl 78 in the pusher 76, thereby causing the pawl78 to engage the slots 68 due to a positive pressure exerted on the pinby the C-shaped spring, and to “lock” into the slots 68. The rotatoryadvancing movement of the needle 26 is therefore controlled to occursequentially through about 280° each time it is actuated.

FIG. 12 shows a cut-away segmental view of the needle 26 in the homeposition inside the cartridge (not shown) with respect to the stemcartridge holder assembly (not shown). The relative locations of thepawl 78 that engages the notches 68 in the radially inner edge of theneedle 26, the thread management roller 72 and the anti-rotate pin 75that engages the notch 70 in the radially outer edge of the needle 26are shown in FIG. 12.

FIG. 13 shows a cut-away view of the needle 26 within the cartridge (notshown) in the “home” position, the alignment of the needle aperture withthe corresponding aperture in the needle cartridge holder 20, therelative position of the needle 26 and cartridge holder 20 and aperturelocation with respect to the coupled shaft segments 10 that are coupledby universal joint coupler 38 and maintained at a fixed angle by therestraining coupling sleeve or “sweep” (not shown).

FIGS. 14-20 show detailed component views of a preferred embodiment ofthe suturing device of the present invention and the manner in which thecomponents are configured to enable its operation as described herein.

FIG. 14 shows the working end of a preferred embodiment of the suturingdevice of the present invention, comprising a “pusher” 9 having asupport arm assembly 80 and a cartridge holder assembly 82 with theattached disposable needle cartridge 84. The “pusher” 9 is connected tothe drive mechanism via shaft segment 86 that is coupled via a universaljoint coupling comprising a universal joint assembly encased in a sleeve(not shown) to a second shaft segment distal to the actuator handle 12.The shaft segment 86 is attached to the universal joint assembly by pinsthat engage slots 88 with corresponding slots in the coupling assembly.

FIG. 15A shows segmental views of the pusher assembly comprising aneedle cartridge 84 engaged with cartridge holder assembly 82. Thecartridge 84 attaches to cartridge holder assembly 82 via a mountingclip 90 located at the apex of the arc of the cartridge holder assembly82 that slidably “locks” into position with a complementary slot 92located correspondingly on the apex of cartridge 84. Both cartridgeholder assembly 82 and cartridge 84 comprise an aperture 96 that are ofsimilar dimension, and aligned with one another in the “locked”position. The cartridge 84 further comprises a suturing materialmanagement cleat 98 which is capable of restrictibly maintainingsuturing material 100 in a manner so as to preclude its entanglement asit travels into cartridge 84 during operation of the suturing device.

FIG. 15B shows a cut-away view of the pusher assembly exposing asuturing needle 102 residing within cartridge 84 (not shown) in the“home” position, wherein the alignment of the needle aperturecorresponds with apertures of both needle cartridge holder assembly 82,and the cartridge 84. The needle 102 is placed in the “home” position byengaging cartridge 84 with cartridge holder assembly 82 in a “lockedposition, whereupon it is restrained by clip 104 in a manner causing itto be engaged with notches located along the radially rear edge of theneedle (not shown) that is proximal to cartridge holder assembly 82 bycorrespondingly located pins in a drive arm located in the cartridgeholder assembly 82 that is part of a “rear-drive” needle rotation driveoperating mechanism.

FIG. 16 shows a preferred embodiment of the curved suturing needle 102of the invention. The needle 102 is formed as a circular split ring withan aperture (or gap) 106, as sharp, pointed end 108 and the opposite end110. A cylindrical bore 112 aligned axially with respect to the needle,located at the blunted 110. The leading end of the suturing material isinserted into the bore and restrained by mechanically crimping.Alternatively, the opening for accommodating the suture material can bein the form of an “eye” wherein the leading end of the suturing materialmay be passed through for attaching it to the needle 102. To enable theneedle 102 to penetrate tissue to the required depth, the needle 102preferably has an arcuate extent between about 280° and about 330°, andmore preferably, greater than about 270°. Needle 26 comprises twosymmetric notches (“rear notches”) 114 along the radially rear edge,i.e. the edge proximal to the cartridge holder 82, that are positionedproximally to the sharp pointed end 108 and the opposite blunt end 110of the needle 102, respectively. The rear notches 114 are locateddirectly opposite to one another, each having a perpendicular (about90°) segment and an angular segment that makes an angle of about 60°with the perpendicular segment. The rear notches 114 are engaged by thedrive mechanism in the cartridge holder assembly and enable the needleto undergo a rotational movement upon actuation of the drive mechanism,thereby causing it to penetrate and advance through tissue. A similartriangular notch 116 is located on the radially outer edge (“outernotch”) of the needle proximally to the rear notch 114 that is closer tothe sharp, pointed end 108. The outer notch 116 engages with an“anti-rotate” pin located in the cartridge holder assembly, wherebyrotation of the needle in a direction opposite to the advancingdirection or “needle backing-up” is prevented. The positive engagementof the needle outer notch 116 during operation, therefore, precludes theneedle from straying out of sequence during the suturing process.

As is evident from FIG. 16, a suturing needle is provided, having acurved toroidal body that defines a longitudinal axis “X” along thecurved toroidal body, wherein the longitudinal axis defines a centerpoint “Y” and the curved toroidal body includes a radially inner surface“A”, a radially outer surface “B”, a first sharp pointed 108 end and asecond end 110, and wherein the longitudinal axis and the center pointof the curved toroidal body define a first plane P1. A first rear notch114 is located proximate the first sharp pointed end 108 of the curvedneedle and on a rear surface “C” of the curved needle disposed betweenthe radially inner surface “A” and the radially outer surface “B”. Thefirst rear notch 114 includes a first engagement surface configured forengaging the needle rotation drive of the corresponding disclosedsuturing device, wherein the first engagement surface is positionedperpendicularly with respect to the first plane P1 and wherein the firstengagement surface lies on the same geometric plane as a first crosssectional plane P2 of the curved toroidal body, wherein the first crosssectional plane is also positioned perpendicularly with respect to thefirst plane P1. Needle further includes a second rear notch 114 locatedproximate the second end 110 of the curved needle and on the same rearsurface “C” as the first rear notch. The second rear notch includes asecond engagement surface configured for engaging the needle rotationdrive of the corresponding disclosed suturing device, wherein the secondengagement surface is positioned perpendicularly with respect to thefirst plane P1 and wherein the second engagement surface lies on thesame geometric plane as a second cross sectional plane P3 of the curvedtoroidal body. The second cross sectional plane P3 is positionedperpendicularly with respect to the first plane P1. Needle furtherincludes an outer notch 116 located on the radially outer surface B ofthe curved needle. The outer notch includes a third engagement surface,wherein the third engagement surface is positioned perpendicularly withrespect to the first plane P1 and lies on the same geometric plane of athird cross sectional plane P4 of the curved toroidal body, wherein thethird cross sectional plane is positioned perpendicularly with respectto the first plane, and wherein the third engagement surface isconfigured for engaging an anti-rotate pin located in the cartridgeholder assembly. It will be appreciated that the foregoing descriptionapplies equally to the needle of FIG. 8, with the exception that thedrive notches are presented on the radially inner surface “A” of theneedle rather than on the rear surface “C”.

FIGS. 17A and 17B show the outer and inner views, respectively, of thecartridge 84. The outer surface of the cartridge 84 (FIG. 17A) comprisesa suturing material management cleat 98 which is capable of restrictiblymaintaining the suturing material in a manner to preclude itsentanglement. The cartridge 84 further comprises a slot 92 located atthe apex of an actuate edge that slidably engages a complementarilylocated pin on the cartridge holder assembly to “lock” it in position.The inner surface of the cartridge 84 comprises a track 118 that permitsthe suturing needle (not shown) housed within to travel in a rotationalmotion from its “home position” so as to span aperture 106 duringoperation. A slot 120 located radially on the inner surface of cartridge84 engages with a complementarily located pin on the cartridge holderassembly such that when the pin is engaged slidably in slot 120, theneedle is constrained to remain in and move along track 118.

FIG. 18 shows a top sectional view of a preferred embodiment of a“pusher” 9 comprising a cartridge holder assembly 82 and support arms22. The cartridge holder assembly 82 comprises a plurality of mountingclips 122 that are capable of receiving the cartridge 84, and a mountingclip 90 at the apex of the radial edge and slidably engaging acomplementarily located slot in the cartridge that engages cartridgeholder assembly 82, thereby causing the drive mechanism in the assembly82 to engage the suturing needle housed within the cartridge. Thecartridge holder assembly 82 further comprises a gate assembly 124 thatprevents needle 102 from leaving its track and falling out into the backof the cartridge holder assembly 82. The gate assembly 124 is maintainedin a closed “home” position by a torque force exerted by a spring 126 towhich it is coupled via a pin 128, thereby restricts lateral movement ofneedle 102. The gate assembly 124 opens during each actuation of thesuturing device to permit a circular movement of the drive mechanismthat engages needle 102, and closes to the home position immediatelyafter passage of the drive mechanism to preclude lateral movement anddislocation of needle 102 within cartridge holder assembly 82.

FIGS. 19A, 19B and 19C show serial views of the “rear-drive” needleoperating drive mechanism operating within the cartridge holder 82 ofthe pusher assembly (not shown). The “rear-drive” mechanism comprises adriver arm 130 connected to a drive shaft 132 that is capable ofcircular motion so as to “sweep” along the circular inner edge of thecartridge holder 82 comprising the gate assembly 124. Actuation of thedevice causes the drive shaft 132 to rotate in a clockwise direction,thereby causing driver arm 130 to move circularly from its “home” restposition and move up to and the past gate assembly 124, causing it toopen in the process (FIGS. 19A and 19B). The driver arm 130 continues tomove circularly until it comes to rest once again in the “home” position(FIG. 19C). The gate assembly 124 returns to its closed home positionafter passage of the driver arm 130, thereby allowing driver arm 130 to“drive” needle 102 in a circular motion, while preventing the needle 102from becoming dislocated from track 118. Thus, each time suturing device1 is actuated, driver arm 130 moves past the gate assembly 124, openingthe gate assembly 124 in the process. Since the gate assembly 124 movesback into its closed “home” position after passage of the driver arm130, it precludes lateral movement of the needle 102, thereby preventingneedle 102 from jamming due to misalignment during operation.

FIGS. 20A, 20B and 20C show the dimensional, sectional and transparentsectional views, respectively, of a ratchet assembly 134 of the presentinvention that is part of the drive mechanism for the suturing device 1.FIG. 20A shows the ratchet assembly 134 comprises a ratchet ring 136with a predominantly arcuate outer surface segment 137 having aplurality of teeth 138, and an arcuate flat segment 140 that having aplanar surface. The ratchet ring 136 includes a central circular bore(not shown) that fits slidably over and attaches immovably to a piniongear 142 comprising a shaft 144. The ratchet ring 136 further comprisesa plurality of wedged surfaces 139 a and 139 b that are proximal to theflat segment 140. The ratchet assembly 134 is mounted on a base 146comprising a housing 148 that accommodates a pawl (hidden) that isactivated by a coil spring (not shown) and a shuttle 150, that isattached to a support bracket 152 by a plurality of screws 153. FIG. 20Bshows a detailed sectional view of the ratchet ring 136 comprising acircular bore 154 that is capable of slidably receiving and attaching tothe shaft 144 of the pinion gear 142 (not shown). The ratchet ring 136is mounted on the base 146 so that the teeth 138 of the ratchet ring 136are interactively meshed with the pawl 156. The pawl 156 is activated bya coil spring (not shown) that exerts a positive pressure on the pawl156 causing it to remain in intimate contact with the teeth 138 of theratchet ring 136. The shuttle 150 is attached to the base so that itallows the ratchet ring 136 to rotate in a unidirectional (such as, forexample, clockwise) until the circular movement is arrested by contactbetween the shuttle 150 and a first wedge 139 a in the ratchet ring 136.Movement of the shuttle 150 after contacting the first wedge 139 apermits the ratchet ring 136 to rotate in a direction opposite to theinitial direction of rotation (such as, for example, counter-clockwise)until the movement is stopped by contact of shuttle 150 with the secondwedge 139 b. FIG. 20C shows a transparent sectional view of the ratchetring 136 where the teeth 138 of the ratchet ring 136 are enmeshed withthe pawl 156, which is maintained in intimate contact with the teeth 138by a positive pressure exerted by the action of a coil spring 158.

The ratchet assembly 134 of the present invention may be suitablylocated within the handle 12 of the suturing device 1. In a preferredembodiment, the ratchet assembly 134 is located at the distal end 8 ofthe actuator handle 12, whereby the shaft 144 of the ratchet assembly134 is a part of a shaft segment 10 that is terminally attached to atriggering mechanism of the suturing device 1. Activation of thesuturing device 1 by actuating the triggering mechanism (not shown) viathe trigger 16 in the actuator handle 12 causes the shaft 144 and theattached ratchet ring 136 and the pinion gear 142 in the ratchetmechanism 134 to rotate unidirectionally, the pinion gear 142 to drivethe shaft segment 10 coupled to the driver arm 130 of the rear-drivemechanism in the pusher 9, which in turn, causes the engaged needle 102to rotate in the same direction to effectuate penetration of incisedtissue by the needle 102 pulling the suturing thread material with it.The rotation of the shaft 144 is arrested after traveling about 280°upon contact by a first wedge 139 a with the shuttle 150, which in turn,terminates the first actuation step. The shuttle 150 then permits theshaft 144 with the attached ratchet ring 136 and the pinion gear 142 torotate through an equal distance in the opposite direction until themovement is stopped once again by the contact by the shuttle 150 withthe second wedge 139 b. An advantage offered by the ratchet mechanism134 of the present invention is that the actuation step of the suturingdevice 1 is pre-determined, that is, the ratchet assembly 134 preventsthe user from performing an incomplete actuating event that could resultin an improper or incomplete suture by causing the needle 102 to snag inthe tissue. Furthermore, the ratchet assembly 134 is capable ofoperation by the trigger 16 in a manner independent of its orientationwith respect to the trigger 16 and actuator handle 12, such as forexample, when it is oriented in an upside down or sidewaysconfiguration.

The actuating means of the suturing device 1 of the present inventionmay comprise of a triggering mechanism that is known in the art, such asfor example, the triggering mechanisms disclosed in U.S. Pat. Nos.6,053,908 and 5,344,061, both of which are hereby incorporated byreference. Alternatively, the actuating means can be either a manuallyoperable button or switch, or a mechanically operable by an automatedelectrical or a fuel driven device, such as for example, an electrical,electromagnetic or pneumatic motor powered by electrical,electromagnetic, compressed air, compressed gas, hydraulic, vacuum orhydrocarbon fuels.

To commence suturing, any embodiment of the suturing device 1 of thepresent invention is placed at the site of the wound or tissue incisionsuch that it spans the wound or the two tissue segments created by theincision, following which it is actuated by operation of the actuatortrigger 16 on the actuator handle 12. The detailed operation of thesuturing device 1 of the present invention is described with referenceto the preferred embodiment, and is equally applicable to all otherembodiments of the invention described and contemplated herein. The pawl156 in the pusher mechanism of the suturing device 1 engages the notch114 located radially rear edge proximal to the blunt end or “tail” ofthe suturing needle 102 and pushes the needle in a circular path in anarc spanning about 280°. The sharp, pointed end 108 of the needle 102crosses the aperture 96 defined by the cartridge 84 and the cartridgeholder 82, and penetrates the first tissue segment located within theaperture 96, traverses the tissue segment to penetrate the second tissuesegment, and re-enters the device on the opposite side of the aperture96. The pusher 9 then returns to its original location, whereupon thepawl 156 engages the notch located radially rear edge 114 proximal tothe sharp, pointed end of the needle 102. The needle 102 with theattached suturing material or thread is consequently pulled in acircular path through an arc of about 280°. The blunt end 110 of theneedle 102 and the suturing material therefore, pass through the tissuesegments and across the wound or incision so as to span the wound orincision. The needle 102 comes to rest at its original “home” positionwithin the track in cartridge holder 82, having advanced through acomplete circular arc of about 360°. The needle 102 including the sharp,pointed end 102 remains entirely contained within the cartridge 84. Thesuturing material or thread may then be cut and secured by anappropriate method, such as for example, by tying, or additionalstitches may be placed along the entire wound or incision by repeatingthe aforementioned process. Every stitch, whether a single, interruptedstitch, or one of a series of continuous, running stitches may be placedin like manner. The suturing device 1 of the present invention,therefore, may be used to insert either a single stitch, or to insert asuture comprising a plurality of continuous stitches as a replacementmethod for a more tedious and time-consuming manual suturing process.

While a suturing device 1 having the separable suture cartridge 84containing the suturing needle 102, a pusher 9 comprising a cartridgeholder 82 with the support arms 80, a drive shaft assembly comprisingthe driver arm 130, and an actuator handle 12 comprising the actuatingtrigger 16 and drive mechanism has been described, the entire suturingdevice 1 can be designed as a single unit which may be either reusableor disposed in its entirety after a single use.

It will thus be seen that the examples set forth above among those madeapparent from the preceding description are efficiently attained in thesuturing device of the present invention. Also, since certain changesmay be made in the above description without departing from the scope ofthe invention, it is intended that all matter contained in the abovedescription or shown in the accompanying drawings shall be interpretedas illustrative, and not in a limiting sense.

1. A suturing device comprising: a) a curved needle; b) a needlerotation drive for driving the needle through a circular path and ananti-rotate member defining a body for controlling the direction ofneedle rotation, the curved needle including: i) a curved toroidal bodythat defines a longitudinal axis along the curved toroidal body, whereinthe longitudinal axis defines a center point; wherein the curvedtoroidal body includes a radially inner surface, a radially outersurface, a first sharp pointed end and a second end, and wherein thelongitudinal axis and the center point of the curved toroidal bodydefine a first plane; ii) a first notch located proximate the firstsharp pointed end of the curved needle and on the inner radial surfaceof the curved needle; the first inner notch including a first engagementsurface configured for engaging the needle rotation drive, wherein thefirst engagement surface is positioned perpendicularly with respect tothe first plane and wherein the first engagement surface lies on thesame geometric plane as a first cross sectional plane of the curvedtoroidal body, wherein the first cross sectional plane is alsopositioned perpendicularly with respect to the first plane; and iii) asecond notch located on the curved needle; the second notch including asecond engagement surface, wherein the second engagement surface ispositioned perpendicularly with respect to the first plane and lies onthe same geometric plane of a second cross sectional plane of the curvedtoroidal body, wherein the second cross sectional plane is positionedperpendicularly with respect to the first plane, and wherein the secondengagement surface is configured for engaging the body of theanti-rotate member for controlling the direction of needle rotation. 2.The suturing device of claim 1, wherein the curved toroidal body has anarcuate extent of less than about 330°.
 3. The suturing device of claim1, wherein the curved toroidal body has a round cross section through amajority of its length.
 4. The suturing device of claim 1, wherein thecurved needle further includes an attachment point defined on the curvedtoroidal body capable of receiving suturing material.
 5. The suturingdevice of claim 4, wherein the attachment point includes an aperture forreceiving suture material.
 6. The suturing device of claim 5, furthercomprising suture material held in place at the attachment point.
 7. Thesuturing device of claim 5, wherein the attachment point is located atthe second end of the needle.
 8. The suturing device of claim 1, whereinthe curved toroidal body has an arcuate extent between about 180° andabout 330°.
 9. The suturing device of claim 1, wherein the needle has anarcuate extent more than about 180°.
 10. A suturing device comprising:a) a curved needle; b) a needle rotation drive for driving the needlethrough a circular path and an anti-rotate member defining a body forcontrolling the direction of needle rotation, the curved needleincluding: i) a curved toroidal body that defines a longitudinal axisalong the curved toroidal body, wherein the longitudinal axis defines acenter point; wherein the curved toroidal body includes a radially innersurface, a radially outer surface, a first sharp pointed end and asecond end, and wherein the longitudinal axis and the center point ofthe curved toroidal body define a first plane; ii) a rear notch locatedproximate the first sharp pointed end of the curved needle and on a rearsurface of the curved needle disposed between the radially inner surfaceand the radially outer surface; the rear notch including a firstengagement surface configured for engaging the needle rotation drive,wherein the first engagement surface is positioned perpendicularly withrespect to the first plane and wherein the first engagement surface lieson the same geometric plane as a first cross sectional plane of thecurved toroidal body, wherein the first cross sectional plane is alsopositioned perpendicularly with respect to the first plane; and iii) asecond notch located on the curved needle; the second notch including asecond engagement surface, wherein the second engagement surface ispositioned perpendicularly with respect to the first plane and lies onthe same geometric plane of a second cross sectional plane of the curvedtoroidal body, wherein the second cross sectional plane is positionedperpendicularly with respect to the first plane, and wherein the secondengagement surface is configured for engaging the body of theanti-rotate member for controlling the direction of needle rotation. 11.The suturing device of claim 10, wherein the curved toroidal body has anarcuate extent of less than about 330°.
 12. The suturing device of claim10, wherein the curved toroidal body has a round cross section through amajority of its length.
 13. The suturing device of claim 10, wherein thecurved needle further includes an attachment point defined on the curvedtoroidal body capable of receiving suturing material.
 14. The suturingdevice of claim 13, wherein the attachment point includes an aperturefor receiving suture material.
 15. The suturing device of claim 14,further comprising suture material held in place at the attachmentpoint.
 16. The suturing device of claim 14, wherein the attachment pointis located at the second end of the needle.
 17. The suturing device ofclaim 10, wherein the curved toroidal body has an arcuate extent betweenabout 180° and about 330°.
 18. The suturing device of claim 10, whereinthe needle has an arcuate extent more than about 180°.
 19. A removablecartridge for attachment to a suturing device comprising: a) a generallycircular, “C”-shaped body having a diameter, a first end and a secondend separated by an aperture, wherein the body includes: (i) an innerperipheral wall that at least in part defines a circular track forreceiving a suturing needle; and (ii) at least one engagement surfacefor engaging a distal end of a suturing device, wherein the body has aheight perpendicular to a circular plane defined by the needle track,wherein the height is substantially less than about one half of thediameter of the body; and b) a toroidally shaped suturing needledisposed in the circular track having a first sharp pointed end and asecond end, wherein the needle is adapted and configured to advancealong the track but is prevented from falling out of the track by atleast one protrusion extending radially inwardly from the inner wall.20. The cartridge of claim 19, wherein the body further defines a cleatfor receiving suture material that depends downwardly and radiallyoutwardly from a distal face of the body, and the cartridge furtherincludes a suture attached to the second end of the needle, wherein thesuture is adapted to be received by the cleat to manage passage of thesuture material therethrough when the cartridge is engaged with thesuturing device.
 21. The removable cartridge of claim 19, wherein theengagement surface includes at least one clip extending from the bodyfor engaging the suturing device.
 22. The removable cartridge of claim19, wherein the engagement surface includes a surface defined by atleast one opening formed in the body for engaging the suturing device.23. The removable cartridge of claim 19, wherein the body traverses anarc greater than about 180 degrees.
 24. The cartridge of claim 19,wherein the cartridge includes a positioning pin disposed thereoncapable of engaging a slot in the suturing device to facilitatealignment of the cartridge with respect to the suturing device.
 25. Thecartridge of claim 19, wherein the cartridge is enclosed in a sterilizedsealed package
 26. The cartridge of claim 19, wherein the needleincludes a notch on a radially outer edge of the needle, the notch beingadapted and configured to engage a body of an anti-rotate member forcontrolling the direction of needle rotation.
 27. A removable cartridgefor attachment to a suturing device comprising: a) a generally circular,“C”-shaped body having a diameter, a first end and a second endseparated by an aperture, wherein the body includes: (i) an innerperipheral wall that at least in part defines a circular track forreceiving a suturing needle; (ii) a cleat for receiving suture material;and (ii) at least one engagement surface for engaging a distal end of asuturing device, wherein the body has a height perpendicular to acircular plane defined by the needle track, wherein the height issubstantially less than about one half of the diameter of the body; b) atoroidally shaped suturing needle disposed in the circular track havinga first sharp pointed end and a second end, wherein the needle isadapted and configured to advance along the track but is prevented fromfalling out of the track by at least one protrusion extending radiallyinwardly from the inner wall; and c) a suture attached to the second endof the needle, wherein the suture is adapted to be received by the cleatto manage passage of the suture material therethrough when the cartridgeis engaged with the suturing device.